The following data is part of a premarket notification filed by Theta Systems, Inc. with the FDA for Isorad(tm) Integral Buildup Photon Diodes.
| Device ID | K912250 |
| 510k Number | K912250 |
| Device Name: | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES |
| Classification | System, Radiation Therapy, Radionuclide |
| Applicant | THETA SYSTEMS, INC. 6425 ANDERSON WAY Melbourne, FL 32940 |
| Contact | Kevin Russell |
| Correspondent | Kevin Russell THETA SYSTEMS, INC. 6425 ANDERSON WAY Melbourne, FL 32940 |
| Product Code | IWB |
| CFR Regulation Number | 892.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-21 |
| Decision Date | 1991-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B01611640006Z0 | K912250 | 000 |
| B01611640003Z0 | K912250 | 000 |
| B01611640002Z0 | K912250 | 000 |
| B01611630006Z0 | K912250 | 000 |
| B01611630003Z0 | K912250 | 000 |
| B01611630002Z0 | K912250 | 000 |
| B01611620003Z0 | K912250 | 000 |
| B01611620002Z0 | K912250 | 000 |